Any of the following events must be reported to the Human Subjects Protection Program office within10 business days of the occurrence: New or increased risk, unanticipated harm related to the research, non-compliance, audit or inquiry by a federal agency, failure to follow protocol, breach of confidentiality, change to the protocol to eliminate an immediate hazard, participant unexpectedly becomes a prisoner, unresolved complaint of a subject, or an unanticipated adverse devise effect. The event must also be reported to the College of Nursing Associate Dean for Research.
- Complete the Reportable Local Information Items that are Potentially Problematic form. This can be found at http://orcr.arizona.edu/hspp.
- Submit the completed form via e-mail to Alice Pasvogel (Office of Nursing Research) at email@example.com.
The Principal Investigator will be notified if additional information is needed.
- The Office of Nursing Research will obtain the signature of the Departmental Chair or Supervisor and send the documents to the University of Arizona Human Subjects Protection Program.